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NCT Number: NCT04389086

Induction Chemotherapy for Locally Recurrent Rectal Cancer

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)

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Key information

Conditions

Recurrent Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Gent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
  • Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.
  • WHO performance score 0-1
  • Written informed consent

Exclusion criteria

  • Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
  • Known homozygous DPD deficiency
  • Any chemotherapy in the past 6 months.
  • Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
  • Radiotherapy in the past 6 months for primary rectal cancer.
  • Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist.
  • Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
  • Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.

Treatment and study plan

Combination drug

Drug

Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg/m2 BSA IV + capecitabine 1000 mg/m2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg/m2 BSA of oxaliplatin IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg/m2 BSA of irinotecan IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles.

If a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX/FOLFIRI.

Other names: CAPOX, FOLFOX, FOLFIRI

Chemoradiotherapy

Radiation

Concomitant chemotherapy agent: capecitabine

Radiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy.

Surgery locally recurrent rectal cancer

Procedure

Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon.

Intraoperative radiotherapy is optional.

Primary outcomes

  1. Proportion of patients with a clear resection margin

    Time frame: Scored within 1 one month of surgery

    A resection margin is considered clear (R0), if there are no tumour cells in any of the resection surfaces as determined by microscopy (resection margin > 0mm)

Secondary outcomes

  1. Local recurrence free survival

    Time frame: Assessed up to 5 years

  2. Progression free survival

    Time frame: Assessed up to 5 years

  3. Metastasis free survival

    Time frame: Assessed up to 5 years

  4. Disease free survival

    Time frame: Assessed up to 5 years

  5. Overall survival

    Time frame: Assessed up to 5 years

  6. Pathologic response

    Time frame: Scored within 1 month of surgery

    Scored according to Mandard

  7. Toxicity induction chemotherapy

    Time frame: Scored until one month after the last administration of the chemotherapy

    Adverse events grade 3 or higher according to the NCI-CTCAE v5.0

  8. Compliance induction chemotherapy

    Time frame: Scored within 1 month after start chemoradiotherapy

  9. Toxicity chemoradiotherapy

    Time frame: Scored until 3 months after the last administration of the radiotherapy

    Adverse events grade 3 or higher according to the NCI-CTCAE v5.0

  10. Compliance chemoradiotherapy

    Time frame: Evaluation at time of surgery

  11. Number of patients undergoing surgery

    Time frame: Surgery is scheduled 10-14 weeks after finishing chemoradiotherapy

  12. Surgical characteristics

    Time frame: Evaluation directly postoperative

    including data on intra-operative radiotherapy

  13. Major surgical morbidity

    Time frame: 30 and 90-days postoperative

    Clavien-Dindo grade 3 or higher

  14. Radiological response

    Time frame: Restaging is performed after 3 cycles of CAPOX (1 cycle is 3 weeks) or 4 cycles of CAPOX/FOLFOX (1 cycle is 2 weeks). Second restaging is performed 4-6 weeks after finishing chemoradiotherapy

    mrTRG

  15. Cancer specific quality of life

    Time frame: at baseline, 3 months and 12 months postoperative

    QLQ-C30

  16. Cost-effectiveness

    Time frame: at baseline, 3 months and 12 months postoperative

    EQ-5D-5L

  17. Colorectal cancer specific quality of life

    Time frame: at baseline, 3 months and 12 months postoperative

    QLQ-CR29

Study contacts

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

Floor Piqeur, MD

CONTACT

[email protected]

0031 40 2397152

Stefi Nordkamp, MD

CONTACT

[email protected]

0031 40 2398858

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

Multicentre, Open-label, Randomised, Controlled, Parallel Arms Clinical Trial of Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Neoadjuvant Treatment for Locally Recurrent Rectal Cancer - PelvEx II

Acronym: PelvEx II

Important dates

Study start
2020
Primary completion
2024
Study completion
2030
First posted
May 15, 2020
Registry last updated
Sep 6, 2022

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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