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NCT Number: NCT06630793

IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer

The standard practice in management of carcinoma of anal canal is to treat patients with radiotherapy using the IMRT technique along with chemotherapy. It is known that while IMRT has reduced treatment related side effects as compared to the older radiation techniques, reducing these side effects further still remains a major challenge.

These side-effects include gastrointestinal (diarrhea, altered bowel habits, weight loss, bleeding, obstruction), genitourinary (difficulties in passing urine, passing blood in urine, difficulty in holding urine) and hematologic toxicities (anemia, low platelet count and increased predisposition to infections).

Proton therapy (IMPT) is a form of radiation treatment in which high doses can be delivered within the tumor while the surrounding normal tissues receive a lesser radiation dose. It is believed that these physical properties of proton therapy may help reduce the side effects of treatment.

Patients will be randomly assigned to either receive IMRT or IMPT based treatment so as to see whether it is possible to reduce the acute treatment related toxicities. In this study, there is a 66.7% chance that the patient will get IMPT based treatment, which may be able to reduce the toxicities.

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Key information

Conditions

Malignant Neoplasm of Anal Canal Anal Canal Carcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location status: Recruiting

Location contact

Rahul Krishnatry, MD

CONTACT

[email protected]

+91-22-24177028 ext. 7028

Rahul Krishnatry, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 and < 80 years of age
  • Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum
  • The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition)
  • Involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on PET CECT may also be included as they receive radical chemoradiation as standard treatment.
  • WHO or ECOG performance status 0-1
  • HIV testing is known and HPV (P16) testing done on tissue sample.
  • With suitable blood test values for standard concurrent chemotherapy (Hb > 10 mg/dL, ANC > 1.5 cells/mm3, Platelets > 100,000 cells/mm3, Creatinine < 1.5 x ULN, Bilirubin < 3 x ULN, ALT < 3 x ULN) as deemed by a medical oncologist in team.
  • The patient must be expected to tolerate the treatment and be compliant for follow up.
  • No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc.
  • Willing to consent to participate in the study.

Exclusion criteria

  • Two or more synchronous primary cancers.
  • When prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in dose calculations, which may affect the treatment planning process.
  • Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
  • Poor reliability for follow-up and treatment completion.

Treatment and study plan

IMPT (Intensity Modulated Proton Therapy)

Radiation

Proton therapy is a form of radiation treatment in which high doses can be delivered within the tumour while relatively sparing the surrounding normal tissues. This may help further reduce the side-effects of radiation treatment observed with IMRT.

IMRT (Intensity Modulated Radiation Therapy)

Radiation

The standard management of carcinoma of the anal canal is radiotherapy using the IMRT technique along with concurrent chemotherapy. The use of IMRT has reduced the treatment-related side-effects as compared to older radiation techniques. However, further reducing these side effects poses a major challenge.

Primary outcomes

  1. Grade 3 or higher acute toxicity

    Time frame: Upto 6 months post-last cytotoxic therapy.

    The highest GI/GU/Hematological toxicity will be captured per patient will be documented using CTCAE v5.0 and the percentage of patients with more than Grade 3 toxicity will be added in each arm and compared proportionately.

Secondary outcomes

  1. Local Failure

    Time frame: 5 years since randomization

    Local control will be computed as the time between randomization and local relapse or progression, Measurable persistent disease after six months from the completion of chemoradiation therapy will be considered a local failure.

  2. Regional Failure

    Time frame: 5 years since randomization

    From randomisation till a situation in which a patient who initially had no signs of disease in the pelvic and groin nodes later displays disease in these nodes after receiving treatment or reappearance of the disease in these nodes after they were initially cleared or the presence of persistent nodal disease for more than six months after completing the treatment.

  3. Distant Relapse

    Time frame: 5 years since randomization

    The rate of relapse of the tumor outside the pelvic region.

  4. Colostomy-free Survival

    Time frame: 5 years since randomization

    From the the time of randomization till the necessity for colostomy is clinically warranted or death due to any cause.

  5. Disease-free Survival

    Time frame: 5 years since randomization

    The time from randomization to local or regional or distant recurrence of tumor or death

  6. Overall Survival

    Time frame: 5 years since randomization

    From randomisation till anal cancer or treatment-related death.

  7. Treatment-related late toxicities

    Time frame: 5 years since randomization

    After 3 months of treatment and up to 5 years or death due to any cause, will be documented using CTCAE v5.0

  8. Patient-Reported Health-Related Quality of Life QLQ-C30 questionnaires

    Time frame: 5 years since randomization

    Will be assessed using Health Related Quality of Life questionnaires (QLQ) of European Organization for Research and Treatment of Cancer (EORTC)

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Rahul Krishanatry, MD

CONTACT

[email protected]

02224177028 ext. 7028

Dr Rahul Krishanatry, MD

CONTACT

[email protected]

02224177028 ext. 7028

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

Phase III Randomised Control Trial of Intensity-Modulated Radiotherapy Using Photon Versus Proton With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer

Acronym: IMPAC

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Oct 8, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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