Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-18

Study Completion Date

2021-09-01

Brief Summary

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The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:

* Is total neoadjuvant treatment in this design safe \& tolerable?
* Impact of this design on treatment related outcomes in terms of pathological and clinical responses.

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Detailed Description

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Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks

Conditions

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Locally Advanced Rectal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short course RT followed by full course of chemotherapy then surgery

Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery.

Group Type EXPERIMENTAL

short course radiation therapy followed by 6 cycles of CAPOX then surgery

Intervention Type RADIATION

Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery

Interventions

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short course radiation therapy followed by 6 cycles of CAPOX then surgery

Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histopathological proof of rectal adenocarcinoma.
* Tumors located within 15 cm and not less than 4 cm from anal verge.
* Age: ≥ 18 years.
* Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).
* ECOG Performance Status: 0-2.

Exclusion Criteria

* Non-epithelial rectal malignancy such as sarcoma or lymphoma.
* Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.
* Recurrent rectal cancer.
* Previous history of malignancy within the last 5 years.
* Previous pelvic irradiation.
* Psychiatric or addictive disorder that would preclude study therapy.
* Concurrent uncontrolled medical conditions.
* Pregnancy or breast feeding.
* Any contraindication to surgery.
* Extensive peripheral neuropathy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No