CClinicalTrials.gg
Status unknownNCT05688033Updated Jan 18, 2023

Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy

An interventional study of dosimetric limitation of pelvic bone and peritoneal space during radiotherapy in Rectal Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Fudan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.

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Conditions studied

  • Rectal Cancer

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 200 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with rectal adenocarcinoma
  2. Clinical staged T3/4 or any node-positive disease
  3. Age of 18-75 years
  4. Karnofsky Performance Status > 80
  5. Adequate bone marrow reserve, renal and hepatic functions
  6. Without previous antitumoural chemotherapy
  7. No evidence of metastatic disease
  8. Written informed consent before randomization
  9. UGT1A1's genotype of 6/6 or 6/7

Exclusion criteria

Exclusion Criteria:

  1. Clinical staged I or IV
  2. Age of \<18 or >75 years
  3. Karnofsky Performance Status \< 80
  4. Previous pelvis radiotherapy
  5. Previous antitumoural chemotherapy
  6. Clinically significant internal disease
  7. Refuse to write informed consent before randomization
  8. UGT1A1's genotype of 7/7
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    experimental arm

    peritoneal space V15\<850cc,pelvic bone V10\<80% and normal dosimetric limitation

    Radiation: dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

  • No intervention
    control arm

    normal dosimetric limitation

Interventions

  • Radiationdosimetric limitation of pelvic bone and peritoneal space during radiotherapy

    dosimetric limitation of pelvic bone and peritoneal space during radiotherapy

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What researchers measure

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: up to 3 years

Secondary outcomes

  1. Number of Participants in Who Experienced Tumor Down-staging

    Time frame: up to 3 years

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Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05688033
Lead sponsor
Fudan University
Responsible party
Zhen Zhang (Professor, Fudan University) — Principal investigator
First posted
Jan 18, 2023
Start date
Jan 1, 2021
Primary completion
Aug 30, 2022
Completion
Dec 30, 2023 (estimated)
Last update
Jan 18, 2023

Study contacts

Zhen Zhang
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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