NCT02533271

Brief Summary

The purpose of this study is to compare effectiveness of short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) in locally advanced rectal cancer. The hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

8 years

First QC Date

August 21, 2015

Last Update Submit

July 10, 2021

Conditions

Cancer, Rectum

Keywords

rectal cancershort-term radiotherapyneoadjuvant chemotherapytotal mesorectal excision

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival rate

    three year

Secondary Outcomes (8)

  • Overall survival rate

    three year

  • Distance metastasis free survival rate

    three year

  • Locoregional recurrence free survival rate

    three year

  • Incidence of surgical complications

    one month

  • Incidence of acute toxicities during radiation or chemotherapy

    three months

  • +3 more secondary outcomes

Study Arms (2)

TNT group

EXPERIMENTAL

The intervention of TNT group is Short-course radiotherapy with neoadjuvant chemotherapy, which consists of a short-course radiotherapy (SCRT, 5 Gy x 5 alone), then after 7-10 days of radiotherapy completed, patients will receive neoadjuvant chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are prescribed preoperatively, then followed by a total mesorectal excision(TME) and postoperative adjuvant chemotherapy. If patients are eligible for postoperative chemotherapy this should consist of at least 2 cycles, which are the same as neoadjuvant chemotherapy.

Radiation: Short-course radiotherapy with neoadjuvant chemotherapy

CRT group

OTHER

The intervention of CRT group is long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively, followed by a total mesorectal excision(TME) and then postoperative adjuvant chemotherapy. The radiotherapy is given in combination with capecitabine in a dose of 825 mg/m2 twice daily on days when radiotherapy, excluding weekends. If patients are eligible for postoperative chemotherapy this should consist of at least 6 cycles of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once every 3 weeks.

Radiation: Long-term chemoradiotherapy

Interventions

Short-course radiotherapy with neoadjuvant chemotherapyRADIATION

Short-course radiotherapy with 4 cycles of neoadjuvant chemotherapy

TNT group
Long-term chemoradiotherapyRADIATION

Standard chemoradiotherapy

CRT group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven rectal adenocarcinoma;
  • Distance between tumour and anal verge≤ 10cm;
  • Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+)
  • Cancer Staging must be based on pelvic MRI;
  • Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
  • Written informed consent;
  • Mentally and physically fit for chemotherapy;
  • Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）
  • No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.

You may not qualify if:

  • Distant metastases;
  • Recurrent rectal cancer;
  • Active Crohn's disease or ulcerative colitis;
  • Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
  • Allergic to Fluorouracil or Platinum drugs;
  • Contraindications to MRI for any reason;
  • Concurrent uncontrolled medical condition;
  • Pregnancy or breast feeding;
  • Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
  • Symptoms or history of peripheral neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

  • Jin J, Tang Y, Hu C, Jiang LM, Jiang J, Li N, Liu WY, Chen SL, Li S, Lu NN, Cai Y, Li YH, Zhu Y, Cheng GH, Zhang HY, Wang X, Zhu SY, Wang J, Li GF, Yang JL, Zhang K, Chi Y, Yang L, Zhou HT, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Wang WL, Liu SX, Gao YH, Li YX. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). J Clin Oncol. 2022 May 20;40(15):1681-1692. doi: 10.1200/JCO.21.01667. Epub 2022 Mar 9.

    PMID: 35263150DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Jing Jin

    Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

    STUDY DIRECTOR

Central Study Contacts

Yuan Tang

CONTACT

+86-15011304945tangyuan82@126.com

Jing Jin

CONTACT

+86-13601365130jingjin1025@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director of Radiotherapy Department

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 26, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2023

Study Completion

August 1, 2025

Last Updated

July 16, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)