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NCT Number: NCT01391065

MR- PET Guided Biologically Optimised Interstitial Brachytherapy

The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features).

The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy.

In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre

Navi Mumbai, Maharashtra, 410210, India

About this study

Aims

Stage I

Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 F-Miso/FLT/Functional MR) image fusion.

Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to biological heterogeneous sub-volumes on imaging.

Stage II:

Aim 3: To evaluate technical feasibility of delivering dose modulated biologically optimized interstitial brachytherapy.

Aim 4: To evaluate acute and late toxicity and quality of life associated with biologically optimized brachytherapy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years.
  • ECOG 0 or 1.
  • Residual/ Recurrent tumor after hysterectomy of cervical cancer.
  • No visceral metastasis.
  • No known contraindication to contrast enhanced MRI/PET scan.
  • Fit for radical treatment (radiotherapy+/-chemotherapy).

Exclusion criteria

  • Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy.
  • Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).

Treatment and study plan

MR PET Guided Brachytherapy

Radiation

Primary outcomes

  1. Local Response in spatial reference to High Risk GTV (as identified by functional imaging)

    Time frame: 3 months after treatment completion

Secondary outcomes

  1. Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy

    Time frame: 2 years after treatment conclusion

    Stage II involves dose modulated brachytherapy wherein higher dose will be delivered to biologically high risk target volume. Saftey will be assessed initially by an interim analysis undertaken at 50 % accrual(median follow up 1 yr). If incidence of grade III-IV rectal and bladder toxicity >15% than the trial will be stopped else continued till target accrual. The technique will be considered to be safe if Grade III bladder and bowel toxicity remain to be under 15%.

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers

Acronym: MR-PET Brachy

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2011
Registry last updated
Apr 7, 2020

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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